What is NDC 0121-0874?

0121-0874 is the product NDC for Cetirizine Hydrochloride, Cetirizine hydrochloride 1 mg/mL solution, listed with the FDA by PAI Holdings, LLC dba PAI Pharma. It has 2 package NDCs, shown above in 10- and 11-digit form.

PAI Holdings, LLC dba PAI Pharma, NDC labeler code 0121. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Cetirizine Hydrochloride?

107 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Cetirizine Hydrochloride NDC 0121-0874

NDC codes

FDA NDC Directory

Product NDC (as listed)0121-0874Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00121-0874Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
0121-0874-04	0012108740400121087404	120 mL in 1 BOTTLE (0121-0874-04)Marketed from Jun 21, 2024
0121-0874-16	0012108741600121087416	480 mL in 1 BOTTLE (0121-0874-16)Marketed from Feb 12, 2024

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Cetirizine Hydrochloride
Generic name (nonproprietary): cetirizine hydrochloride
Active ingredients: Cetirizine hydrochloride — 1 mg/mL
Dosage form: Solution
Route: Oral
Labeler: PAI Holdings, LLC dba PAI PharmaNDC labeler code 0121
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078412
Marketing start: Feb 12, 2024
Listing expires: Dec 31, 2026
Other FDA classes: Histamine H1 Receptor Antagonists (Mechanism)
Identifiers: Product ID 0121-0874_31dc1106-c6ed-4dcd-81e3-206cbd47017bSPL ID 31dc1106-c6ed-4dcd-81e3-206cbd47017bSPL set ID 71448ab0-e23e-4cf7-940e-7d67e7362fb4RxCUI 1014673UNII 64O047KTOA
Pharmacologic class: Histamine-1 Receptor Antagonist

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N400121087404 followed by a unit qualifier and the quantity

Package 00121-0874-04. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Jun 19, 2024.

Indications (excerpt from the label)

INDICATIONS AND USAGE Perennial Allergic Rhinitis Cetirizine hydrochloride is indicated for the relief of symptoms associated with perennial allergic rhinitis due to allergens such as dust mites, animal dander and molds in children 6 to 23 months of age. Symptoms treated effectively include sneezing, rhinorrhea, postnasal discharge, nasal pruritus, ocular pruritus, and tearing. Chronic Urticaria Cetirizine hydrochloride is indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in children 6 months to 5 years of age. It significantly reduces the occurrence, severity, and duration of hives and significantly reduces pruritus.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0121-0874

What is NDC 0121-0874?: 0121-0874 is the product NDC for Cetirizine Hydrochloride, Cetirizine hydrochloride 1 mg/mL solution, listed with the FDA by PAI Holdings, LLC dba PAI Pharma. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Cetirizine Hydrochloride.
What is the active ingredient?: Cetirizine hydrochloride.
Who is the labeler?: PAI Holdings, LLC dba PAI Pharma, NDC labeler code 0121. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Cetirizine Hydrochloride?: 107 other product NDCs are listed under this name. See all Cetirizine Hydrochloride NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Cetirizine Hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Cetirizine Hydrochloride	Cetirizine hydrochloride 5 mg/1	TabletOral	First Nation Group, LLC	81469-352	81469-0352-01
Cetirizine Hydrochloride	Cetirizine hydrochloride 10 mg/1	TabletOral	First Nation Group, LLC	81469-353	81469-0353-0181469-0353-0381469-0353-05+1 more
Cetirizine Hydrochloride	Cetirizine hydrochloride 10 mg/1	Tablet, Film coatedOral	Safecor Health, LLC	48433-017	48433-0017-20
Cetirizine hydrochloride	Cetirizine hydrochloride 1 mg/mL	SolutionOral	Advagen Pharma Ltd.,	72888-480	72888-0480-01
cetirizine hydrochloride	Cetirizine hydrochloride 10 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-4072	68788-4072-0368788-4072-0668788-4072-09
Cetirizine Hydrochloride	Cetirizine hydrochloride 1 mg/mL	SolutionOral	Bionpharma Inc.	69452-426	69452-0426-5569452-0426-88
Cetirizine Hydrochloride	Cetirizine hydrochloride 1 mg/mL	SolutionOral	Rising Pharma Holdings, Inc.	57237-357	57237-0357-1257237-0357-24
Cetirizine Hydrochloride	Cetirizine hydrochloride 1 mg/mL	SolutionOral	Rising Pharma Holdings, Inc.	57237-358	57237-0358-1257237-0358-24
Cetirizine Hydrochloride	Cetirizine hydrochloride 1 mg/mL	SolutionOral	BAJAJ MEDICAL, LLC	61037-480	61037-0480-2261037-0480-2361037-0480-24+2 more
Cetirizine Hydrochloride	Cetirizine hydrochloride 1 mg/mL	SolutionOral	BAJAJ MEDICAL, LLC	61037-480	61037-0480-0261037-0480-0361037-0480-04+2 more

All 108 Cetirizine Hydrochloride NDCs